Cataracts Clinical Trial
Official title:
Laser Cataract Surgery With the Femtosecond Laser Technology
Verified date | October 2011 |
Source | Innovative Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye. - Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation. - The surgeon may use the Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity. Exclusion Criteria: - Concurrent participation or participation in the last 30 days in other clinical trials. - Known steroid IOP responder. - Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, etc.). - Acute or chronic disease or illness that would increase risk or confound study results(e.g. uncontrolled diabetes mellitus, immunocompromised, etc.). - Uncontrolled systemic or ocular disease. - Corneal abnormalities (e.g. stromal, epithelial, or endothelial dystrophies) - Pseudoexfoliation. - Ocular hypertension (>or =20hg) or glaucomatous changes in the optic nerve. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Loden Vision Centers | Goodlettsville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Innovative Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular Pressure | Measure the fluid pressure inside the eye. | three month | No |
Primary | Uncorrected and Best corrected Visual Acuity | Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected). | three month | No |
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